Prescription drug · ANDA
Rocuronium Bromide NDC 82449-001
Rocuronium bromide 50 mg/5mL · Injection, Solution · Intravenous · STERISCIENCE SPECIALTIES PRIVATE LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82449-001-02 | 8244900010282449000102 | 10 VIAL, MULTI-DOSE in 1 CARTON (82449-001-02) / 5 mL in 1 VIAL, MULTI-DOSE (82449-001-01)Marketed from Nov 30, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Rocuronium Bromide
- Generic name (nonproprietary)
- rocuronium bromide
- Active ingredients
- Rocuronium bromide — 50 mg/5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- STERISCIENCE SPECIALTIES PRIVATE LIMITEDNDC labeler code 82449
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217092
- Marketing start
- Listing expires
- Other FDA classes
- Neuromuscular Nondepolarizing Blockade (Physiologic effect)
- Identifiers
- Product ID 82449-001_77cc97bc-4ea2-414f-bbf7-8eaaca4c1eaeSPL ID 77cc97bc-4ea2-414f-bbf7-8eaaca4c1eaeSPL set ID b894c436-ea67-407e-a801-f334a0c0c2d9RxCUI 1234995UNII I65MW4OFHZ
- Pharmacologic class
- Nondepolarizing Neuromuscular Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N482449000102followed by a unit qualifier and the quantityPackage 82449-0001-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. ROCURONIUM BROMIDE INJECTION is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 82449-001
- What is NDC 82449-001?
- 82449-001 is the product NDC for Rocuronium Bromide, Rocuronium bromide 50 mg/5mL injection, solution, listed with the FDA by STERISCIENCE SPECIALTIES PRIVATE LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rocuronium Bromide.
- What is the active ingredient?
- Rocuronium bromide.
- Who is the labeler?
- STERISCIENCE SPECIALTIES PRIVATE LIMITED, NDC labeler code 82449. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rocuronium Bromide?
- 53 other product NDCs are listed under this name. See all Rocuronium Bromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rocuronium Bromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rocuronium Bromide | Rocuronium bromide 50 mg/5mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-507 | 43066-0507-05 |
| Rocuronium Bromide | Rocuronium bromide 100 mg/10mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-509 | 43066-0509-05 |
| Rocuronium Bromide | Rocuronium bromide 50 mg/5mL | InjectionIntravenous | B. Braun Medical Inc. | 0264-5711 | 00264-5711-10 |
| Rocuronium Bromide | Rocuronium bromide 50 mg/5mL | InjectionIntravenous | Lifestar Pharma LLC | 70756-669 | 70756-0669-1070756-0669-85 |
| Rocuronium Bromide | Rocuronium bromide 100 mg/10mL | InjectionIntravenous | Lifestar Pharma LLC | 70756-670 | 70756-0670-1070756-0670-86 |
| Rocuronium Bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-130 | 65145-0130-10 |
| Rocuronium Bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-131 | 65145-0131-10 |
| Rocuronium Bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7372 | 71872-7372-01 |
| Rocuronium Bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-131 | 84549-0131-10 |
| Rocuronium Bromide | Rocuronium bromide 50 mg/5mL | Injection, SolutionIntravenous | Shandong New Time Pharmaceutical Co., Ltd. | 42677-309 | 42677-0309-10 |